At the urging of US federal regulators, Pfizer and Modern extend their clinical trials to children ages 5 to 11, according to a New York Times article.
As noted, this is a precautionary measure to detect rare side effects, including inflammation of the heart, which have occurred in vaccinated people under 30 years of age.
The US Food and Drug Administration (FDA) pointed out on Pfizer-BioNTech and Moderna that the size and scope of pediatric studies, as originally envisaged, were insufficient to detect rare side effects. These include myocarditis and pericarditis, according to people familiar with clinical trials.
The FDA has asked companies to include 3,000 children in the 5-11 age group, a group whose results are expected first, according to people familiar with the developments. One of them described the number as double the original number of participants.
Moderna spokesman Ray Jordan confirmed that the company intends to expand clinical trials “to include a larger base that increases the likelihood of more rare cases” and expects to apply for an emergency license later this year or early next. year.
The Moderna clinical trial began gathering volunteers in March with the goal of gathering 6,795 participants under the age of 12. Participants were to be divided into three age groups, including that of 6-11, with 2,265 participants each. The company is now discussing with US regulators the extension of the clinical trial.
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